MAUDE Adverse Event Report: JOLIFE AB LUCAS(T) CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Rupture (2208)

Event Date 08/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) the device has not been made available to physio-control for evaluation.A clinical review of the journal article was performed by jolife and physio-control with the following conclusions: in this case there was a use error in the placement of the suction cup, based on the reported observation, that below the lower sternum there was a hematoma with the shape of the device¿s plunger which overlapped the left liver side.In addition, the patient was anticoagulated.The serious injury reported in this case was likely due to a use error.Note: the device operating instructions include the following warning: ¿warning - incorrect position over chest if the pressure pad is not in the correct position in relation to the sternum, there is an increased risk of damage to the rib cage and the internal organs.Also, the patient's blood circulation is compromised.¿ a representative from jolife will attempt to follow up with the author regarding the use error.(b)(4).

Event Description

During a literature search an article from (b)(6) ("der unfallchirurg - doi 10.1007/s00113-015-0045-4"von springer-verlag berlin heidelberg 2015) was found.The following case was described in the article: following a cardiac arrest a (b)(6) male patient was treated with a lucas device.During treatment the patient (who was on anticoagulation) developed a liver rupture with abdominal bleeding and abdominal compartment.Further details on the event: according to received information the patient collapsed at his work place.He was not provided with (lay) cpr immediately.On arrival of the emergency doctor the patient suffered from vf, which probably was related to an acute coronary syndrome (acs).The patient was known for coronary artery disease with a successful bypass surgery.It was not possible to confirm the received patient history during the emergency situation.After 45 minutes of cpr with a lucas device the patient had rosc.And the patient was transferred to a hospital.After the surgery the patient developed circulatory instability again which resulted in vf.The patient was cpr'ed again with a lucas device.A re-coronary angiography that was performed under emergency circumstances did not need a new procedure.The patient however still was hemodynamically instable.An abdominal ultrasonography was performed which showed free abdominal liquid.After transfusion of 10 packs of blood (at the emergency station and during the transport) the was transferred to the hospital's "shock" department where a computed tomography supported by contrast liquids was performed.This showed liver laceration with an active bleeding.An emergency laparotomy was performed immediately.During this treatment several "parenchymrisse" of segment ii were observed.Corresponding to a liver rupture 2nd degree (moore) at the left liver lobe was diagnosed.The next day a re-laparotomy with "depacking" of the liver was performed.The patient stabilized and could be transferred to a normal hospital ward after 30 days in intensive care.When the patient was taken into the hospital it was observed that below the lower sternum there was a hematoma with the shape of the device铠(lucas) plunger which overlapped the left liver side.A further, certainly considerable risk factor of the patient was the initial therapy with antiplatelet agents.

• Brand Name: LUCAS(T) CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; scheelevägen 17; ideon science park; lund SE 22 3 70; SW SE 223 70
• Manufacturer (Section G): JOLIFE AB #3005445717; scheelevägen 17; ideon science park; lund ; SW
• Manufacturer Contact: jason march ; 11811 willows rd ne; redmond, WA 98052
• MDR Report Key: 5066121
• MDR Text Key: 25342705
• Report Number: 3015876-2015-01108
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/10/2015
• Event Location: Hospital
• Date Manufacturer Received: 08/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 51 YR